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COVID-19 Vaccine Clinical Trials: A Bird's Eye Perspective

Pujitha Vallivedu Chennakesavulu1, Gaurav Venkat Cuddapah1, Mayura Reddy Keesara2

  • 1Internal Medicine, Kamineni Academy of Medical Sciences and Research Centre, Hyderabad, IND.

Cureus
|September 19, 2022
PubMed

Insights

This review examines Phase-III COVID-19 vaccine trials, focusing on safety and effectiveness across diverse populations and variants. Evidence is synthesized for mRNA, protein, adenoviral, and inactivated virus vaccines.

Area of Science:

  • Immunology
  • Vaccinology
  • Epidemiology

Background:

  • Over a year after the initial COVID-19 outbreak, numerous Phase-III clinical studies on vaccine safety and efficacy have emerged.
  • Vaccine candidates utilize diverse platforms: mRNA, recombinant protein, adenoviral vector, and inactivated virus.
  • Existing trial data has limitations due to participant selection, geography, and epidemic dynamics.

Purpose of the Study:

  • To review scientific evidence from Phase-III clinical trials of COVID-19 vaccines.
  • To assess vaccine safety and effectiveness in specific populations (elderly, pregnant/nursing women, adolescents).
  • To evaluate vaccine performance against asymptomatic infections and emerging viral variants.

Main Methods:

  • Systematic review of published Phase-III clinical trial data.
  • Analysis of vaccine candidate performance across different technological platforms.
  • Examination of subgroup data for diverse demographic groups and viral strains.

Main Results:

  • Vaccine candidates show varying safety and efficacy profiles.
  • Data gaps exist for specific populations and against asymptomatic/variant infections.
  • Evidence synthesis for mRNA, recombinant protein, adenoviral vector, and inactivated virus vaccines.

Conclusions:

  • Phase-III trials provide initial insights into COVID-19 vaccine performance.
  • Further research is crucial to address safety and effectiveness in underrepresented groups and against new variants.
  • Comprehensive understanding requires ongoing evaluation of real-world effectiveness.
Keywords:
clinical trials in all phases (i-iv)covid 19covid-19 vaccinecovid-2019infectious and tropical diseasespreventive healthsars-cov-2severe acute respiratory syndrome coronavirus-2 (sars-cov-2)

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